Top 5 Deficiencies for Laboratories

As a Quality Advisor, I spend a lot time speaking with labs that are either brand new, in the process of getting started, or laboratories that have been in operation for years. One interesting thing I find is that, regardless of whether the lab is new or has been accredited for years, there are some common areas where labs tend to have deficiencies and therefore receive citations. Here's some insight into what I've designated as the Top 5 Deficiencies for Laboratories and How to Prevent Them.

Personnel: This area tends to be one of the top cited; one reason is lack of awareness about personnel requirements for the complexity of the testing being performed. Another reason is personnel files not being complete, often the files are missing the correct type of proof of education (Diploma, Transcript), the training checklist for when the employee was first hired (or training that took place when new tests were added) or a job description. Competency Assessment also tends to get included in this category. The requirement for Competency is to have an assessment done six months post hire and then yearly after that. To prevent deficiencies in this area ensure that you are familiar with CLIA, State and your specific Accreditation Agency's personnel requirements for the complexity level of your lab (waived, moderate, and high). Also, make sure to have a robust Competency Assessment plan and a calendar or reminders in place to ensure assessments are done on time.

Proficiency Testing: When it comes to deficiencies in proficiency testing (PT), what I see most often is labs not treating proficiency testing samples the same as patient samples. Sometimes this can be a source of confusion for labs. The Physician Office laboratories (POLs), as well as labs that are short staffed or have staff working less than full time, have to ensure everybody who performs patient testing has an opportunity to participate in performing Proficiency Testing. Attestation forms not being signed and corrective action not being performed for failed PT events are also among the most common reasons why this area may be deficient. To prevent deficiencies in PT, ensure that attestation forms are signed by both testing personnel and the lab director. Also, ensure that Proficiency Testing samples are treated the same as patient samples. A schedule must be devised to ensure that part time staff gets to participate in PT. Remember, Proficiency Testing serves as a test of your laboratory's processes, the competency of your staff and is a good indicator of the level of quality in your lab.

Quality Control (QC): For QC the issue encountered most often is lack of appropriate corrective action. Running a control repeatedly until it comes in does not fix the problem! A root cause analysis must be done to determine the real reason behind the QC failure. If the lab has documented corrective action consistently, sometimes by reviewing the corrective action log one can determine what the real problem is. In other instances, a more in depth investigation may be needed. Another situation I see often is laboratories that choose to run QC and patients simultaneously. For some systems running QC before running patients is just not time efficient or even possible. But if the system allows it, my recommendation is to always run QC first and make sure that it is in PRIOR to running patients.

Stay tuned for Part II of this blog where we will touch on Calibration and Quality Assurance. How does this compare with your experience of the most common areas where labs tend to have deficiencies? Which ones would you have selected?

18 comments

The comment you made on quality control, that one must first run a QC's and then patient sample. How then is one suppose to evaluate within run variation and proceed with the validation of results batch

Itai, thanks for your comment. Granted, some instruments may not allow you to do this, as stated earlier. However, for instruments that do not require QC and patients to be run together, the best practice is to run QC first, ensure that QC is in, and then run patient samples. Regardless of the situation, the idea is to take ensure QC is in prior to releasing patient results. This practice should be universal regardless of the type of setup. Hope this helps.

Nancy Alers, Lab Quality Advisor

March 19, 2014 10:43 AM

BaltimoreMD

The comment you made on quality control, that one must first run a QC's and then patient sample. How then is one suppose to evaluate within run variation and proceed with the validation of results batch

Itai, biochemistry - technologist, tertiary

March 19, 2014 5:45 AM

Harare

I have been a generalist for forty-two years. With all of the added testing ie flu screens, trich screens, pos blood culture smears, synovial fluid analyisis, etc., that the ER phys. want stat on off shifts; it seems that there is no room for generalist. I feel that I would like to be proficient in one area then be a jack of all trades and master of none.

Any thoughts?

Teresa, generalist - medical technologist March 14, 2014 5:22 PM

detroit MI

Teresa,

Thank you for sharing your comments. Sounds like you may enjoy more concentrating in one area vs. being the Jack of all trades, as you mentioned. Please check out one of my blogs in the next few weeks that talks about an issue related to your comment about STATs.

Nancy

Nancy Alers, Quality - Lab Quality Advisor

March 15, 2014 4:16 PM

BaltimoreMD

I have been a generalist for forty-two years. With all of the added testing ie flu screens, trich screens, pos blood culture smears, synovial fluid analyisis, etc., that the ER phys. want stat on off shifts; it seems that there is no room for generalist. I feel that I would like to be proficient in one area then be a jack of all trades and master of none.

Any thoughts?

Teresa, generalist - medical technologist

March 14, 2014 5:22 PM

detroitMI

Loretta,

Thank you for your question, I have seen this situation first hand. As Sheryl mentioned there are ways to go about it and she certainly mentioned a few options. Another option is to contact the Department of Education in the State where the school was. There should records available even if the school does not exist anymore.

Thanks again for your comments! Stay tuned everyone for part II of this blog! We appreciate your participation!

Nancy Alers, Lab Quality Advisor

March 14, 2014 10:51 AM

BaltimoreMD

Loretta - It may be possible to get records of education for techs that have been in the field for a long time for your files. When I moved to TN from another state, I had to get proof of education. The program I trained with in the early 1980's no longer exists. I contacted my college for a transcript, and then contacted NACCLS for proof that I was trained in an approved program. To upgrade my Tennessee MT license to a supervisor license, I had to prove years of experience. Of course, the last lab I worked at in my previous state no longer existed and no one knew where the HR records were. I was able to track down someone I worked with at that lab who was now a lab manager, and she wrote a letter stating how long I had been in the field.

It may be a time-consuming process, but it can be done.

Sheryl, Chief Technologist

March 14, 2014 9:29 AM

TN

The deficiencies you mentioned are some that we have worked on over the years. Competency is continually adapting to new requirements and is an area that takes a great deal of effort. I agree that HR should check new hires for education, but how do you document the education of techs who have been working 30+ years and do not have a diploma on file because it was not part of the HR process when they were hired? Some of the original colleges no longer exist and the employee cannot locate a copy of their degree. Any suggestions? Thanks.

Loretta, Laboratory - Manager

March 14, 2014 8:02 AM

PA

Thank you! That is VERY well stated! I have worked in this field for approximately 20 years, and have [unfortunately] encountered every laboratory "deficiency" you mentioned. In my opinion, all of these issues are under-acknowledged and/or ignored, and must be recognized and addressed!

The other bullet points that I would include are: 1) poor management, and 2) workplace bullying.

Both are rampant and acceptable, in this industry, and need to be dealt with

syed ali mohammad, histopathology - assistant manager, hospital

March 14, 2014 1:00 AM

karachi

Thank You Nancy for that blog, as just being inspected I agree. The five areas you had mentioned occur every year in some manner no matter how long the Laboratory has been inspected. As Vivian mentioned, the smaller the Laboratory the more hats the manager will wear. These area's are not missed maliciously but sometimes are over looked. CAP currently has over 3000 checklist items, something is bound to get overlooked.

In my opinion, the root cause of many deficiencies is inadequate staffing, especially support staff. There is a trend to decrease the number of FTEs while adding more and more clerical type duties to technologists workload. What I see with my own situation, is that I do not have time to attend to writting the procedure manual and the like - my days are filled with putting out fires and completing everything necessary to produce patient results.

Pamela, cytotechnologist - staff, Beebe Healthcare

March 13, 2014 6:03 PM

LewesFL

To Ugiomoh Fred,

Does Nigeria have an regulatory or accreditation bodies available to periodically check on all anatomical and clinical laboratories across the country? Because there may be a propensity for errors (probably my opinion) if laboratories do not have operating manuals (SOPs) to work with. Thanks.

The five top deficiencies you had mentioned occur frequently in many laboratories. In my view, I see the deficiencies as weaknesses if we should consider or measure the SWOT analysis of these laboratories. . But laboratories can use these weaknesses as opportunities for both continuing education and organizational growth. Since all of the five deficiencies are decisive for professional development and accreditation purposes, I sumbit it should be taken very seriously. No laboratory is considered effective in quality standards when such parameters as proficiency, qualified staff, quality control, and so on are missing.

I agree with all the comments. In small hospital facilities, one person is expected to do 10 jobs and it is getting impossible. New MT's or MLT's often do not have the training or experience to sucessfully accept responsibility for a lab section. They do not understand why or what needs to be accomplished. How does one deal with this and still keep the lab in compliance with the endless regulations we are subjected to? Wondering!!

Vivian, MT - Lab Dir, Hospital

March 13, 2014 5:40 PM

ParkerAZ

Alan,

Thank you for your comments, I just want to add a few ore ideas regarding your statement: "Personnel education should be checked by the HR department before a person is even hired."

Yes, you are absolutely right! and in most large hospital labs with a separate HR department this may not be much of an issue. However, smaller labs and POLs can be a different story.

Also, there's the situation when a lab upgrades their test menu. For example, if personnel is qualified to perform moderate complexity testing, adding a high complexity test could provide another opportunity where personnel qualifications may fall short.

Thanks again for your feedback!

Nancy

Nancy Alers

March 6, 2014 3:22 PM

Thank you everyone for your comments!! Any more suggestions for what I should write about on part II of this blog?

Nancy Alers, Laboratory Quality Advisor

March 6, 2014 3:05 PM

BaltimoreMD

Personnel education should be checked by the HR department before a person is even hired. I agree that training schedules are a big problem along with PT. SOPs are almost considered a given. Any lab that is certified by CMS or one of their designated organizations will have some sort of SOP. The guidelines for writing an SOP are clearly stated by CAP/CMS. If they pass their criteria, then mistakes may be more of a education/experience issue.I admire the lean six sigma approach to QA/QC. However, laboratories are not assembly lines. Each day brings a new set of dynamic challenges. The need is of good management and experienced personnel that work well as a team.

Alan Galeana

March 6, 2014 7:03 AM

Well said I have worked close to 10years also have sincerely what you have written is also applied in Nigeria as deficiencies to add to this some laboratories do not have SOPs and MOP standard of operations and mode of operations which are the keys to a success in laboratories which makes them stand out among the lots and at the same time have in organizational strength and to be in turn for quality management system.

Thank you!!!! That is VERY well stated! I have worked in this field for approximately 10 years, and have [unfortunately] encountered every laboratory "deficiency" you mentioned. In my opinion, all of these issues are under-acknowledged and/or ignored, and must be recognized and addressed!

The other bullet points that I would include are: 1) poor management, and 2) workplace bullying.

Both are rampant and acceptable, in this industry, and need to be dealt with.